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Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion

A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05807984
Enrollment
31
Registered
2023-04-11
Start date
2023-05-01
Completion date
2026-12-31
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer, Recurrent

Brief summary

Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)

Interventions

RADIATIONCarbon ion radiation therapy DT: 74Gy/20 fractions

patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation

Sponsors

Xin Cai
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

carbon ion therapy

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 1\) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis, * 2\) received a radical operation for their primary tumor and regional lymph nodes, * 3\) received chemo-radiation or radiation in pelvic before CIRT, * 4\) received re-irradiation by CIRT after their pelvic radiotherapy.

Exclusion criteria

* 1\) received more than once prior radiotherapy in the same treatment field, * 2\) time to the last radiotherapy was \<1 year, * 3\) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (\<5 mm).

Design outcomes

Primary

MeasureTime frameDescription
local controlLocal control at 3 years after CIRTlocal control rate of the lesion treated by CIRT

Secondary

MeasureTime frameDescription
overall survival3 years after CIRT or patient died, measured erery 3 months after CIRTsurvival rate after CIRT
progression free survival3 years after CIRT or patient died, measured erery 3 months after CIRTprogression free survival rate after CIRT

Countries

China

Contacts

Primary ContactXin Cai, Doctor
xin.cai@sphic.org.cn+86 13901601072
Backup ContactZheng Wang, Doctor
zheng.wang@sphic.org.cn+86 021-38296666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026